DIAPACT CRRT

K973322 · B.Braun Medical, Inc. · KDI · Nov 10, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K973322
• Device Name: DIAPACT CRRT
• Applicant: B.Braun Medical, Inc.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Nov 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Diapact is an extracorpeal blood purification septem intended to be used for acute renal failure. The septem provides high flow continuous rinal replacement therapies, emergency intermittent dialipis and plasmapheresis.

Device Story

Diapact CRRT is an extracorporeal blood purification system for acute renal failure management. It performs high-flow continuous renal replacement therapy (CRRT), emergency intermittent dialysis, and plasmapheresis. The system processes blood extracorporeally to remove toxins or manage fluid balance. It is intended for clinical use by healthcare professionals. The device functions as a blood purification platform, providing therapeutic support for patients with renal dysfunction. Clinical benefit is derived from the restoration of fluid and solute balance in acute settings.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and intended use similarities to predicate devices. Finished products undergo physical testing and visual examination per established quality control procedures.

Technological Characteristics

Extracorporeal blood purification system. Materials, form, and design are identical to predicate devices. Operates as a single patient dialysate delivery system. Subject to 21 CFR 876.5820/876.5860. Manufacturing follows cGMP and Quality System Regulation (21 CFR Part 820).

Indications for Use

Indicated for patients with acute renal failure requiring extracorporeal blood purification, including high flow continuous renal replacement therapies, emergency intermittent dialysis, and plasmapheresis.

Regulatory Classification

Identification

A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.). (3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).

Special Controls

*Classification.* Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ” (2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,” (3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,” (4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and (5) “Guidance for Hemodialyzer Reuse Labeling.”

Predicate Devices

• SPECTRA - Blood Component Separator Therapeutic (K900105)
• PRISMA - CFM - Continuous Fluid Management System (K946279)

Submission Summary (Full Text)

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NOV 1 0 1998

K973322
p. 1/2

# II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90

B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem, PA 18018 [phone]

September 2, 1997

CONTACT: Mark S. Alsberge, Regulatory Affairs Director

PRODUCT NAME: Diapact CRRT

TRADE NAME: Dialyzer . High Permeability with or Without Sealed Dialysate System

### CLASSIFICATION NAME:

Gastroenterology & Urology -Class III, 78 KDI, Single Patient Dialysate Delivery System 21 CFR 876.5820

#### SUBSTANTIAL EQUIVALENCE1 TO:

| 510 (k) Number | Applicant | Description |
|----------------|-------------------------|------------------------------------------------------|
| K900105 | Cobe Laboratories, Inc. | SPECTRA - Blood Component<br>Separator Therapeutic |
| K946279 | Cobe Renal Care Inc. | PRISMA - CFM - Continuous Fluid<br>Management System |

### DEVICE DESCRIPTION:

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce the DIAPACT CRRT - ( Continuous Renal Replacement Therapies). It is an extracorpeal blood purification system intended to be used for acute renal failure. The system provides high flow continuous renal replacement therapies, emergency intermittent dialysis treatment and plasmapheresis.

¹ The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product technology used to manufacture the product.

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# SUBSTANTIAL EQUIVALENCE:

The DIAPACT CRRT is identical in materials, form, and intended use to the PRISMA - CFM Continuous Fluid Management System and the SPECTRA - Blood Component Separator Therapeutic currently marketed by Cobe. There are no new issues of safety and effectiveness raised by Diapact CRRT.

#### SAFETY AND EFFECTIVENESS:

..

All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product).

The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.

The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control cGMP"s.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV I n 1998

Mr. Mark S. Alsberge Regulatory Affairs Director B. Braun Medical, Inc. 824 12th Avenue Bethlehem, Pennsylvania 18018-0027 Re: K973322

Diapact CRRT Dated: August 11, 1998 Received: August 14, 1998 Regulatory Class: III 21 CFR 876.5860/Product code: 78 KDI unclassified/Product code: 78 LKN

Dear Mr. Alsberge:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmadsmam.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|-------------------------|
| 510(k) Number (if known): | K973322 |
| Device Name: | Drapact CRRT |

# Indications For Use:

Indications For Use:
Diapact is an extracorpeal blood
purification septem intended to be
used for acute renal failure. The
septem provides high flow continuous
rinal replacement therapies, emergency
intermittent dialipis and
plasmapheresis.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|-----------------------------------------------------------------------|-----------------------------------------------|
| | |
| (Division Sign-Off) | <i>Willian yn</i> |
| Division of Reproductive, Abdominal, ENT,<br>and Radiological Devices | |
| 510(k) Number | K973322 |
| Prescription Use<br>(Per 21 CFR 801.109) | <div> <img alt="Tick" src="tick.png"/> </div> |
| | OR |
| Over-The-Counter Use | ____________________ |

(Optional Format 1-2-9G